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FDA 510(k)

Kepler II

K-Number: K163265 · 2017-04-07

ApplicantOrbbo Surgical, LLC
Decision Date2017-04-07
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kepler II is a medical device manufactured by Orbbo Surgical, LLC. It received FDA 510(k) clearance on 2017-04-07 under approval number K163265. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kepler II?

Kepler II is a medical device that received FDA 510(k) clearance on 2017-04-07. It is manufactured by Orbbo Surgical, LLC. The 510(k) number is K163265.

When was Kepler II approved by the FDA?

Kepler II received FDA 510(k) clearance on 2017-04-07, under approval number K163265.

What company makes Kepler II?

Kepler II is manufactured by Orbbo Surgical, LLC.

What is the FDA product code for Kepler II?

The FDA product code for Kepler II is ODP.

Other Devices by Orbbo Surgical, LLC

K163180Hubble II K163602Kepler I Cervical Plate System K163566Hubble I System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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